MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Corroded (1131)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 09/12/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "corrosion at the head-neck taper as a cause for adverse local tissue reactions after total hip arthroplasty" written by h.John cooper, md, craig j.Della valle, md, richard a.Berger, md, matthew tetreault, ba, wayne g.Paprosky, md, scott m.Sporer, md, and joshua j.Jacobs, md published by the journal of bone and joint surgery, incorporated published online 12 september 2012 was reviewed.The article's purpose was to describe the clinical presentation, diagnosis, and early results of operative treatment of patients with corrosion at the modular head-neck junction of a metal-on-polyethylene total hip prosthesis.It is noted that only 1 of the 10 patients has depuy products.Patients presented with pain and some patients had elevated ion levels.Intraoperatively, patients presented with hypertrophy of the synovial tissue and pseudotumor with varying degrees of hip abductor muscle necrosis.All patients had removal of abnormal hypertrophic tissue and all femoral head-neck junctions had obvious corrosion seen as black, flaky material (noted as metal debris within discussion) at the base of the taper.Femoral stem was left intact and trunnion was cleaned as it was inspected and deemed as "the structural integrity of the trunnion was maintained in all ten implants." femoral heads and liners were replaced at revision.No note of wear on liners.Case #9 (the only patient with depuy product) is a 55.5 year old female with depuy bantam full porocoat pinnacle product listed as the femoral component with a 10/12 taper and head size of 28 mm and neck length of +5 with a co alloy/co alloy receiving revision at 8.9 years post initial implantation.She received a head and liner exchange to a metal 28 mm head and a constrained liner.Her ion levels were 3.18ng/ml for co and 1.60 ng/ml for cr.No complications after revision surgery.Depuy products utilized: femoral stem, co alloy head, poly liner, pinnacle cup adverse event: corrosion at taper junction, revision, pain, pseudotumor, metallic debris, muscle necrosis, synovial tissue hypertrophy.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9384946
• MDR Text Key: 185061370
• Report Number: 1818910-2019-118475
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention